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America’s Blood Centers (ABC) submitted these formal comments to the Food and Drug Administration (FDA) in response to a draft guidance on responding to FDA Form 483 observations at the conclusion of a drug CGMP inspection.

ABC supports FDA’s draft guidance on responding to Form 483 observations and appreciates its focus on effective corrective actions and blood sup...


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Key Takeaways A study analyzed blood donor and product characteristics affecting platelet transfusion outcomes using a vein-to-vein database. Key findings include that higher donor BMI and SARS-CoV-2 anti-N Ab levels correlated with increased platelet increments. Pathogen reduction and specific storage methods negatively impacted platelet increments but did not affect RBC...

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Key Takeaways The Non-DEHP study in Vox Sanguinis evaluated bacterial growth in red blood cell concentrates (RBCCs) stored in DEHT and DEHP containers. Researchers collected whole blood in DEHT bags, pooled it into DEHP-free containers, and analyzed bacterial proliferation for four relevant species. Findings showed no statistical difference in overall quality parameters b...

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Every state presents its own advocacy challenges, and opportunities. To support our members navigating this complex landscape, ABC has developed a wide range of advocacy resources tailored for state-level engagements. These tools are designed to complement members’ existing efforts, strengthen legislative relationships, and provide practical support grounded in the collective...


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Key Takeaways A study published in JAMA Internal Medicine shows that RBC exchange transfusion (ET) benefits patients with severe babesiosis. Patients treated with ET had a significant reduction in parasitemia and better clinical outcomes than those not treated with ET. The study enrolled 629 patients, with 33.2% receiving ET during hospitalization and 3.6% of ET ...

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